The Food and Drug Administration has approved the Latuda (lurasidone HCI; Sunovion) supplemental New Drug Application (sNDA), expanding the drug’s indication to treat pediatric patients aged 10-17 years with major depressive episodes associated with bipolar I disorder

Latuda, an atypical antipsychotic, is already approved to treat adults with bipolar depression as a monotherapy and adjunctive therapy with lithium or valproate, and to treat adolescents and adults with schizophrenia. 

“The FDA approval of this medicine for the treatment of pediatric patients with bipolar depression is significant for several reasons,” said Robert Findling, MD, MBA, Director of Child & Adolescent Psychiatry at Johns Hopkins University. “First, it is a new treatment option for this vulnerable group of young people. Also, it is the first single-agent formulation to receive regulatory approval for this pediatric indication.” 

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The approval is supported by Phase 3 clinical trial results involving 347 individuals (aged 10-17 years) with bipolar depression who were randomized to receive once-daily Latuda flexibly dosed (20-80mg/day) or placebo. Results demonstrated that the Latuda-treated group had significant and clinically meaningful improvement from baseline to Week 6 on the Children’s Depression Rating Scale, Revised (CDRS-R) and the Clinical Global Impression-Bipolar Version Severity of Illness (CGI-BP-S) score compared to placebo. At Week 6, the change in CDRS-R score in the Latuda group was -21.0 vs -15.3 for placebo (P<0.0001), and the change in CGI-BP-S score in the Latuda group was -1.49 vs. -1.05 (P<0.0001).

The most common treatment-emergent adverse events seen in Latuda vs placebo groups were nausea (16.0% vs 5.8%), weight gain (6.9% vs 1.7%) and insomnia (5.1% vs 2.3%). 

Latuda is available in 5 tablet strengths: 20mg, 40mg, 60mg, 80mg and 120mg.

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